MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. POLARSHEATH; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number M004CRBSUSC3050

Device Problems Leak/Splash (1354); Device Contamination with Body Fluid (2317); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

Event Type  malfunction  

Event Description

(b)(6).During a pulmonary vein isolation cryoablation procedure to treat atrial fibrillation a polarsheath was selected for use.It was reported that the blue cap located on the end of the sheath became detached during the procedure.The cap was placed back into procedure and the procedure resumed.After cryo-ablation was completed with the polarx balloon, the physician proceeded to perform a cavo-tricuspid isthmus (cti) line ablation.A 7 french catheter was introduced into the polarsheath.During aspiration, air ingress was noted coming in through the hemostatic valve.Subsequently continually leakage of blood was seen from the proximal end of the valve.The polarsheath was exchanged for a boston scientific direx sheath and the procedure was completed successfully with no patient complications.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

Event Description

Clinical study frozen af py004.During a pulmonary vein isolation cryoablation procedure to treat atrial fibrillation a polarsheath was selected for use.It was reported that the blue cap located on the end of the sheath became detached during the procedure.The cap was placed back into procedure and the procedure resumed.After cryo-ablation was completed with the polarx balloon, the physician proceeded to perform a cavo-tricuspid isthmus (cti) line ablation.A 7 french catheter was introduced into the polarsheath.During aspiration, air ingress was noted coming in through the hemostatic valve.Subsequently continually leakage of blood was seen from the proximal end of the valve.The polarsheath was exchanged for a boston scientific direx sheath and the procedure was completed successfully with no patient complications.This product is part of the 92688876-fa advisory population for the polarsheath steerable sheath.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Visual inspection noted that the sheath cap was detached and the shaft was returned into a knot.Insufficient adhesive was applied to the attached location.The received polarsheath passed all standard testing procedures (pressure decay, aspiration, hemostasis).A tear was observed on the outer slit of the hemostatic valve and a possible distortion on the inner slit was also seen.The sheath did not pass extensive engineering testing in the hemostasis phase while inserting, angling and withdrawing a polarx catheter from the sheath.The device also did not pass aspiration while a polarx was angled and withdrawn from the sheath valve.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: POLARSHEATH
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park, la aurora; heredia ; CS
• MDR Report Key: 11701789
• MDR Text Key: 246695850
• Report Number: 2134265-2021-05133
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/02/2021
• Device Model Number: M004CRBSUSC3050
• Device Lot Number: 0025898304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Date Manufacturer Received: 05/07/2021
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 70